SafeOp Patient Interface recall: Software Issue
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Why was SafeOp Patient Interface recalled?
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
- Product
- SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- Recalling firm
- Alphatec Spine, Inc.
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of TX, MO, IN.
- Recall date
- July 29, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)